Site Name: UK - Hertfordshire - Stevenage, Belgium-Wavre, Canada - Ontario - Mississauga, GSK HQ, USA - Pennsylvania - Upper Providence
Posted Date: Jan 24 2025
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Job Purpose and Key Responsibilities:
The primary responsibility of the NIS Planning and Delivery (NIS P&D) Study Delivery Lead (SDL), Associate Director, is to lead the full lifecycle of clinical studies and trials within the Non-Interventional Study (NIS) portfolio. This includes designing, executing, and reporting interventional studies, complex regulatory commitment studies (such as PASS and registries), and large multicentre, multi-country primary data studies. Additionally, this role may involve leading and managing team members within the NIS P&D Team.
In this role you will be responsible for:
* Planning and leading the delivery of assigned studies to timelines, quality, budget, company standards and scientific requirements; from concept to final study report and archiving. Including the assessment, selection, engagement, and management of appropriate vendors. Act as the primary contact for vendor at study level.
* Ensuring compliance with ICH/GCP & ENCePP guidelines and/or applicable guidelines for NIS such as Good Pharmacovigilance Practices (GVP), Good Epidemiological Practices (GEP) and CIOMS, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
* Proactively generating ideas for above-study improvements and implementing new business processes and strategies. Driving innovative approaches to study delivery through external facing advances in technology and sciences.
* Supporting the technical and leadership development of NIS Planning & Delivery staff through mentoring and coaching and may also be responsible for line managing NIS P&D Study Delivery Leads and/or industrial placement students.
Basic Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor’s degree in life sciences or related discipline.
* Proven experience in clinical operations or related research.
* In-depth knowledge of study management, essential regulatory guidelines worldwide, and the clinical development process.
* Excellent leadership, influencing and negotiation skills. Ability to work independently and proactively and to take on leadership roles on cross-functional teams.
* Ability to build strong relationships and collaborate successfully, managing trusted stakeholder relationships internally and externally at all levels in a highly dynamic and matrixed environment.
Preferred Requirements:
Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:
* Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience.
* Knowledge and experience of Non-Interventional Studies (NIS).
* Proven expertise in the proactive identification of issues which may impact clinical programmes coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
* Demonstrated experience leading in both matrix and line environment to deliver projects, develop clinical plans, and manage change.
* Proven experience in managing relationships with vendors to ensure successful delivery of projects.
Closing Date for Applications – Friday 7th of February (COB)
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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